- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01597882
Improving Monitoring of Patients Receiving Case Management
Improved Targeting of Admission Avoidance Interventions in Older People With Long-term Conditions:An Observational,Longitudinal Study Exploring the Feasibility of Measures of Strength as a Monitoring Aid in Patients Receiving Case Management
The UK population is ageing and the likelihood of having a long term health condition increases with age. Three out of every five people over 60 in the UK have a long term condition. Ageing and having a long term condition increases the chance of having difficulty being independent and carrying out day to day activities. In recent years the NHS has made a greater effort to prevent these difficulties in patients with long term conditions.
One approach to help patients with long term conditions is case management, where by (usually) a community matron visits patients at home, looking for early warning signs of any worsening of their condition and arranging care and treatment. But the current way this is done varies across the country and hospital admissions are still rising. In order to give the right care at the right time, effective monitoring is needed to help the community matron detect and act on changes in the patient's condition.
Loss of muscle strength in old age is linked to a poor health, but it is not known whether simple measures of muscle strength could be used to detect and predict declines in health in the short to medium term to help maintain independence and prevent an accident or hospital admission.
The aim of this study is to look at whether monitoring muscle strength in case managed patients is practical, acceptable and useful in detecting when a patient's condition worsens. Each patient will be visited by the researcher in their home twice in the first week, then once every two weeks, for another 5 weeks, to carry out three simple measures of grip and respiratory strength, and complete questionnaires about their health and ability to carry out day to day activities. Each visit will last about 20 to 30 minutes. A small group of clinicians will be asked about their views of the strength measures. Database analysis will allow descriptive data on the patient group to be gathered and analysed.
Study Overview
Status
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Portsmouth, United Kingdom, PO4 8LD
- Solent NHS Trust
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Southampton, United Kingdom, PO13 0FH
- Southern Health NHS Foundation Trust
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- Patients aged 65 years or over receiving health case management in the community.
Exclusion Criteria:
- Enrolled in any other research study
Preclude consent:
- Significant cognitive impairment resulting in lack of capacity to consent. b. Unable to communicate without significant aids e.g. Non-English speaking.
Preclude participation/ collection of data
- Significant emotional distress or psychotic illness active within the last 6 months.
- Receiving end of life care.
- Current illness that would preclude data collection.
- Upper limb pathology that would limit participation e.g. bone fracture within the previous 6 months.
- Identified as high risk patients with regards to lone working safety by their case manager.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
Cohorts and Interventions
Group / Cohort |
|---|
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Case managed patients
Patients aged 65 years and over receiving community case management.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
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Grip strength
Time Frame: 13 weeks
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To assess reliability of measure over a one week period and the stability of the measure over 13 weeks, in this patient group, as well as acceptability.
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13 weeks
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Peak expiratory flow
Time Frame: 13 weeks
|
To measure reliability over one week and stability over 13 weeks in this patient group, as well as acceptability.
|
13 weeks
|
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Peak inspiratory flow
Time Frame: 13 weeks
|
To assess reliability over one week, and stability over 13 weeks in this patient group, as well as acceptability.
|
13 weeks
|
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Sickness behaviour scale
Time Frame: 13 weeks
|
To explore the relationship between sickness behaviour and measures of strength.
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13 weeks
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Nicola Barnes, MPharm, University of Southampton
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8550
- 1409-ERGO (Other Identifier: University of Southampton)
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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